Article 5. Powers of Federal Executive Bodies with Respect to Circulation of Medicines

Powers of federal executive bodies with respect to circulation of medicines include:

1) pursuing of a unified state policy in the area of supply of the citizens with medicinal products in the Russian Federation;

2) approval of general pharmacopeia monographs and pharmacopeia monographs and enactment of the state pharmacopeia;

3) provision of state control and supervision;

4) licensing of manufacturing of medicines and pharmaceutical activities in compliance with the legislation of the Russian Federation;

5) arrangement of medicines expert examination and ethical expert examination of the possibility to conduct a clinical trial of a medicinal product for medical use;

6) issue of permits for conducting clinical trials of medicinal products; maintenance of the register of issued permits for the conduct of clinical trials of medicinal products;

7) state registration of medicinal products; maintenance of the state register of medicines;

8) inspection of manufacturing of medicines for compliance with the good manufacturing practices; issue of conclusions on compliance of medicines manufacturers with the requirements of the good manufacturing practices;

9) state registration of maximum ex-works prices for the vital and essential medicinal products determined by the manufacturers of the medicinal products and maintenance of the state register of the manufacturers’ maximum ex-works prices for the medicinal products included in the list of vital and essential medicinal products;

10) establishment of the procedure for import of medicines into the Russian Federation and export of medicines from the Russian Federation;

11) foundation of councils responsible for issues related to circulation of medicines;

12) evaluation and certification of specialists;

13) approval of professional training programs;

14) safety monitoring of medicinal products;

15) participation in international cooperation;

16) obtaining information related to determination and use of prices for medicinal products and mark-ups to the prices from executive bodies of the constituent entities of the Russian Federation, as well as from the subjects of circulation of medicines for medical use, at the requests of the authorized federal executive body;

17) imposing of sanctions for violation of the legislation of the Russian Federation;